Postoperative Chemoradiotherapy With S-1 in Gastric Cancer

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: S-1

• Registration Number: NCT01824004
• Lead Sponsor: Chonnam National University Hospital

Brief Summary

This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.

Detailed Description

Surgery is the only possible curative treatment of gastric cancer. However, the high recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite the benefit of CRT on local recurrence, the distant recurrence is the leading pattern of failure. We hypothesized that gastric cancer outcome could be improved using a more effective chemotherapy regimen. This study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-10
• Study Completion: 2012-06
• Study First Submitted: 2013-03-28
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-03
• Last Update Submitted: 2013-04-03
• Study First Posted: 2013-04-04
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Age > 18 years

• Histologically proven gastric adenocarcinoma which is complete resected

• ECOG performance status of 1 or lower

• Adequate bone marrow function

  • absolute neutrophil count [ANC] ≥1,500µL, and platelets ≥100,000/µL

• Adequate kidney function (serum creatinine < 1.5 mg/dL)

• Adequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL) serum transaminases levels <2 times UNL

• No prior chemotherapy

Exclusion Criteria

• Other tumor type than adenocarcinoma
• Evidence of distant metastasis
• Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
• Uncontrolled infection
• Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry
• History of significant neurologic or psychiatric disorders including dementia or seizures
• Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
• Symptoms of gastrointestinal obstruction
• concomitant drug medication: The following drugs cause drug interaction with S-1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-1,chemoradiotherapy, adjuvant treatment	S-1	Pts with radically D2 resected adenocarcinoma of the stomach or GEJ in AJCC stage Ib-IV (M0) were eligible for this study. Pts were treated with S-1 (40-60 mg depending on BSA) b.i.d. for 3 wks, and cisplatin (60 mg/m²) iv on day 1, followed by a 2-wk rest period, within a 5-wk cycle. Subsequently, radiotherapy (RT) started which consisted of 25 fractions of 1.8 Gy to a total dose of 45 Gy in 5 wks (5 fractions/wk). On RT days, S-1 (40-60 mg depending on BSA ) b.i.d., 5 days/wk was given. One month after the completion of RT, two 5-wk cycles of S-1/ciplatin chemotherapy were given.

Primary Outcome Measures

Name	Time	Method
Disease free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival	3 years
Number of participants with adverse events as a measure of safety and tolerability	3 year

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun-Eup, Jeollanam-do, Korea, Republic of